Safety and Efficacy of S-8184 in Second Line Treatment of Relapsed Stage IIIB or IV Non Small Cell Lung Cancer

NCT00034164 | Completed Phase 2

• 1 other identifier: SON-8184-1063
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Phase IIA, multicenter, dose escalation study evaluating the safety and efficacy of weekly S-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed stage IIIB or IV non small cell lung cancer.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• To determine the objective response rate

  After all patients completed therapy

Secondary Outcomes (1)

• To determine time to disease progression

  After all patients completed therapy

Interventions

S-8184 Paclitaxel Injectable Emulsion DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologic diagnosis of non small cell lung cancer
• Relapsed or unresectable stage IIIB or IV disease
• One and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent dosed at 60 mg/m2 or higher per cycle for cisplatin and AUC 6 per cycle for carboplatin
• Documented response of at least stable disease while on first line therapy
• Adult (18 years of age or older) patients
• Adequate hematologic function (ANC greater than 1500 cells/mm3 and platelets greater than 100,000/mm3)
• Serum creatinine less than 2.0 mg/dL
• Total bilirubin less than 1.5 mg/dL; SGOT and SGPT less than 3 times the upper limit of institutional normal values
• ECOG performance status of 0 - 2
• Bidimensional measurable or clinically evaluable disease
• Patients who have signed an IRB / Ethics Committee approved informed consent
• Life expectancy at least 12 weeks
• Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery)
• Patient has a negative pregnancy test prior to study entry if premenopausal. (Patients of child bearing potential must use a medically effective form of contraception during the treatment.)

You may not qualify if:

• Patients who have received any taxane-containing preparation including Taxol (paclitaxel) or Taxotere (docetaxel)
• Patients with intracranial metastases having neurologic function stabilized for less than 4 weeks prior to study entry
• Females who are pregnant or lactating
• Patients with peripheral neuropathy NCI-CTC grade 2 or greater
• Patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry
• Patients who have had an investigational agent within 4 weeks of study entry
• Patients receiving concurrent anticonvulsants known to induce P450 isoenzymes

Sponsors & Collaborators

• Achieve Life Sciences: lead

Study Sites (1)

Unknown Facility

3 Cities, Russia

Location

Related Links

• sponsor's home page

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2002
• First Posted: April 24, 2002
• Study Start: April 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: June 4, 2009

Record last verified: 2009-06

Locations

RU (1)